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Draft standard

DIN EN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Edition 2024-04

Standards [CURRENT]

DIN EN ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
Edition 2020-04

Draft standard

DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
Edition 2023-05

Standards [CURRENT]

DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019
Edition 2020-04

Standards [CURRENT]

DIN EN ISO 11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017
Edition 2017-11

Standards [CURRENT]

DIN EN ISO 11138-8

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021); German version EN ISO 11138-8:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 11737-2

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
Edition 2020-07

Standards [CURRENT]

DIN EN ISO 12736-1

Oil and gas industries including lower carbon energy - Wet thermal insulation systems for pipelines and subsea equipment - Part 1: Validation of materials and insulation systems (ISO 12736-1:2023); English version EN ISO 12736-1:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 13849-2

Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012); German version EN ISO 13849-2:2012
Edition 2013-02

Standards [CURRENT]

DIN EN ISO 14064-3

Greenhouse gases - Part 3: Specification with guidance for the verification and validation of greenhouse gas statements (ISO 14064-3:2019); German and English version EN ISO 14064-3:2019
Edition 2020-05

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